Randomized, Open Label, Multicenter Phase III Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets Versus Best Available Care

Inclusion Criteria:

- Subjects diagnosed with PV for at least 24 weeks prior to screening according to the
2008 World Health Organization criteria

- Subjects resistant to or intolerant of hydroxyurea

- Subjects with a phlebotomy requirement

- Subjects with a palpable splenomegaly and a spleen volume of greater than or equal to
450 cubic centimeters

- Subjects with an ECOG performance status of 0, 1 or 2

Exclusion Criteria:

- Women who are pregnant or nursing

- Subjects with inadequate liver or renal function

- Subjects with significant bacterial, fungal, parasitic, or viral infection requiring
treatment

- Subjects with an active malignancy within the past 5 years, excluding specific skin
cancers

- Subjects with known active hepatitis or HIV positivity

- Subjects who have previously received treatment with a JAK inhibitor

- Subjects being treated with any investigational agent